Oval heart valve prosthesis, delivery system and method of use

Abstract

A heart valve prosthesis includes a frame and a prosthesis disposed within an inner lumen of the frame. The frame includes a plurality of struts and a crown and has a radially collapsed state and a radially expanded state. A stiffness of the plurality of struts is varied by varying a width of at least one of the plurality of struts such that the frame has a substantially elliptical shape when the frame is in the radially expanded state.

Description

TECHNICAL FIELD

[0001] The present invention relates to an elliptical heart valve prosthesis, and a system and method for delivering and deploying an elliptical heart valve prosthesis. More particularly, the present invention relates to an elliptical heart valve prosthesis in which the width of the struts of the heart valve prosthesis is varied to form an elliptical shape. BACKGROUND

[0002] The human heart is a four-chambered muscular organ that provides blood circulation throughout the body during a cardiac cycle. The four main chambers include the right atrium and right ventricle that provide pulmonary circulation, and the left atrium and left ventricle that provide oxygenated blood received from the lungs to the rest of the body. To ensure that blood flows through the heart in one direction, atrioventricular valves (tricuspid and mitral valves) exist between the junctions of the atria and ventricles, and semilunar valves (pulmonary and aortic valves) govern the outlets of the ventricles to the lungs and other parts of the body. These valves contain leaflets or cusps that open and close in response to changes in blood pressure caused by the contraction and relaxation of the chambers of the heart. The leaflets separate from one another to open and allow blood to flow downstream of the valve, and coapt to close and prevent backflow or regurgitation upstream.

[0003] Diseases associated with heart valves, such as those caused by injury or defects, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis narrows and hardens the valve, which prevents blood from flowing to downstream heart chambers at an appropriate flow rate and can cause the heart to work harder to pump blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow back, resulting in decreased efficiency of the heart. Valvular disease or damage can be congenital, age-related, drug-induced, or in some cases caused by infection, possibly leading to enlargement, thickening of the heart, thereby losing elasticity and efficiency. Some symptoms of heart valve disease can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia, and edema, as well as blood clots that can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to debilitate and / or endanger a person.

[0004] In recent years, heart valve prostheses for percutaneous trans-catheter delivery and implantation have been developed. The heart valve prosthesis is radially compressed or collapsed for delivery in a catheter, then advanced through the aorta, for example through an opening in the femoral artery, and then deployed in the annulus of a native heart valve. The valve prosthesis is typically formed by attaching a bioprosthetic valve to a frame or stent made of wire or wire mesh. The valve prosthesis can be deployed by radial expansion once positioned at the desired deployment site.

[0005] Most heart valve prostheses have a circular cross-section. However, a significant number of patients have mitral valves that are non-circular or elliptical in shape. Circular or ring-shaped heart valve prostheses deployed within non-circular or elliptical native anatomy are at increased risk for paravalvular leakage (PVL), a serious post-implantation condition. Therefore, there is a need for improved elliptical heart valve prostheses, as well as systems and methods for deploying elliptical heart valve prostheses. Summary of the Invention

[0006] Embodiments of the present invention relate to a heart valve prosthesis comprising: a frame including an inner lumen; and a prosthetic valve disposed within the inner lumen of the frame. The frame further comprises a plurality of struts forming a plurality of crowns, an inflow end, and an outflow end opposite the inflow end. The frame further comprises a radially contracted state and a radially expanded state. The stiffness of the plurality of struts varies such that, when the frame is in the radially expanded state, the cross-section of the frame is substantially elliptical.

[0007] In any embodiment, the stiffness of the plurality of struts can be varied by varying the width of at least one of the plurality of struts such that, when the frame is in a radially expanded state, at least one of the plurality of struts having the largest width is positioned adjacent to the major axis of the frame and at least one of the plurality of struts having the smallest width is positioned adjacent to the minor axis of the frame.

[0008] In any embodiment, the width of each of the plurality of struts of the frame can be selected from the group consisting of a first strut width, a second strut width, a third strut width, a fourth strut width, and a fifth strut width.

[0009] In either embodiment, at least one of the inflow end or the outflow end of the frame comprises eighteen crowns formed by struts from the plurality of struts. In either embodiment, the width of each of the plurality of struts forming the eighteen crowns is selected from the group consisting of a first width, a second width, a third width, a fourth width, and a fifth width. In either embodiment, each of the eighteen crowns is formed by two struts, such that the plurality of struts consists of thirty-six struts, the thirty-six struts including four struts having a first width, eight struts having a second width, eight struts having a third width, eight struts having a fourth width, and eight struts having a fifth width, wherein the second width is greater than the first width, the third width is greater than the second width, the fourth width is greater than the third width, and the fifth width is greater than the fourth width. In either embodiment, the crown formed by struts having the fifth width is positioned adjacent to the minor axis of the frame, and the crown formed by struts having the first width is positioned adjacent to the major axis of the frame.

[0010] In either embodiment, the plurality of crowns at at least one of the inflow end or the outflow end are non-planar when the frame is in a radially contracted state, and the plurality of crowns at at least one of the inflow end or the outflow end are substantially planar when the frame is in a radially expanded state.

[0011] In either embodiment, the plurality of struts at the inflow end and the plurality of struts at the outflow end may have non-uniform lengths.

[0012] In any embodiment, at least one of the inflow end or the outflow end comprises a crown of a plurality of crowns, and the width of each of the plurality of struts forming the crown at the outflow end or the inflow end is selected from the group consisting of a first width, a second width, a third width, a fourth width, and a fifth width.

[0013] In either embodiment, the prosthetic valve can include four leaflets.

[0014] In either embodiment, the frame can be balloon expandable.

[0015] Embodiments of the present invention relate to a system for percutaneously delivering a heart valve prosthesis to the site of a native heart valve. The system includes a delivery catheter and a heart valve prosthesis positioned at a distal portion of the delivery catheter in a radially contracted configuration for delivery. The heart valve prosthesis includes a radially expanded configuration, wherein the heart valve prosthesis has a substantially elliptical shape, the substantially elliptical shape being formed by varying the stiffness of at least one of a plurality of struts of a frame of the heart valve prosthesis.

[0016] In either embodiment, the stiffness of at least one strut can be varied by varying the width of at least one strut. In either embodiment, when the heart valve prosthesis is in the radially expanded configuration, at least one strut of the plurality of struts having the greatest width is positioned adjacent to the minor axis of the heart valve prosthesis, and at least one strut of the plurality of struts having the smallest width is positioned adjacent to the major axis of the heart valve prosthesis.

[0017] In either embodiment, the heart valve prosthesis can be balloon-expandable, the delivery catheter can include a balloon at a distal portion thereof, the balloon having an inflated state in which the cross-section of the balloon is substantially elliptical, and the heart valve prosthesis in a radially contracted configuration can be positioned over the balloon in an uninflated state such that the major axis of the heart valve prosthesis is circumferentially aligned with the major axis of the balloon.

[0018] In any embodiment, the delivery catheter can further include a radiopaque marker coupled thereto and aligned with the long axis of the balloon.

[0019] Embodiments of the present invention also relate to methods for deploying a substantially elliptical heart valve prosthesis. The methods include loading a substantially elliptical heart valve prosthesis in a radially collapsed configuration onto a delivery catheter, positioning the delivery catheter with the heart valve prosthesis at a native heart valve, aligning a long axis of the heart valve prosthesis with a long axis of an annulus of the native heart valve, and deploying the heart valve prosthesis at the annulus of the native heart valve.

[0020] In any embodiment, the heart valve prosthesis can be balloon-expandable, and the step of loading the substantially elliptical heart valve prosthesis onto the delivery catheter can include crimping the substantially elliptical heart valve prosthesis onto an outer surface of a substantially elliptical balloon in an un-inflated state, wherein a long axis of the heart valve prosthesis is aligned circumferentially with a long axis of the balloon, and the step of deploying the heart valve prosthesis includes transitioning the balloon from the un-inflated state to an inflated state to transition the heart valve prosthesis from the radially collapsed configuration to the radially expanded configuration.

[0021] In any embodiment, the delivery catheter can include a radiopaque marker aligned with the long axis of the substantially elliptical balloon and the long axis of the substantially elliptical heart valve prosthesis, and the step of aligning the long axis of the heart valve prosthesis with the long axis of the annulus of the native heart valve includes aligning the radiopaque marker with the long axis of the annulus of the native heart valve.

[0022] In any embodiment, the native heart valve can be a native aortic valve, a native mitral valve, a native pulmonary valve, or a native tricuspid valve.

[0023] In any embodiment, the native heart valve can be a native aortic valve, a native mitral valve, a native pulmonary valve, or a native tricuspid valve. BRIEF DESCRIPTION OF DRAWINGS

[0024] Figure 1 depicts a schematic side view of a heart valve prosthesis according to embodiments of the present invention, wherein the heart valve prosthesis is in a radially expanded configuration.

[0025] Figure 2 depicts a perspective view of a frame of a heart valve prosthesis according to embodiments of the present invention, wherein the frame is in a radially expanded configuration. Figure 1

[0026] Figure 3 depicts a top view of a heart valve prosthesis according to embodiments of the present invention, wherein the heart valve prosthesis is in a radially expanded configuration. Figure 1

[0027] depicts a partial side view of a portion of a frame of a heart valve prosthesis according to embodiments of the present invention. Figure 4 Figure 1

[0028] Figure 5 ​​​a partial side view of an inflow end of a frame of a heart valve prosthesis of Figure 1

[0029] Figure 6 a side view of a frame of a heart valve prosthesis of Figure 1

[0030] Figure 7 a side view of a frame of a heart valve prosthesis of Figure 1

[0031] Figure 8 an end view of a heart valve prosthesis of Figure 1

[0032] Figure 9 a side view of a system for delivering, positioning, and deploying a substantially elliptical heart valve prosthesis.

[0033] Figure 10 a side view of a distal portion of a system of Figure 9

[0034] Figure 11 a side view of a distal portion of a system of Figure 9 Figure 10

[0035] Figure 12A a cross-sectional view taken along line 12A-12A of Figure 9

[0036] Figure 12B a cross-sectional view of an alternative embodiment of a delivery catheter of Figure 9

[0037] Figure 12C a cross-sectional view of an embodiment of Figure 12B

[0038] Figure 13 a cross-sectional view of a balloon of a system of Figure 9

[0039] Figure 14 a cross-sectional view of a balloon of a system of Figure 9

[0040] Figure 15 a cross-sectional view of a balloon of a system of Figure 9 ​​​​​​​​​​​​the system of FIG. 1 is delivered to the site of the native aortic valve and deployed Figure 14 is rotated.

[0041] Figure 16 a cross-sectional view of a native heart is depicted, wherein Figure 9 the balloon of the system of FIG. 1 is inflated to radially expand the heart valve prosthesis.

[0042] Figure 17 a cross-sectional view of a heart is depicted, wherein after the heart valve prosthesis has been radially expanded at the site of the native aortic valve, Figure 9 the delivery catheter of the system of FIG. 1 is removed. DETAILED DESCRIPTION

[0043] Reference will now be made to specific embodiments of the application, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used in different drawings to refer to the same or like elements. The terms "distal" and "proximal," when used in the following description in reference to a delivery system or catheter, are with respect to the position or orientation of the treating clinician. Thus, "distal" and "distally" refer to a position away from or in a direction away from the treating clinician, while the terms "proximal" and "proximally" refer to a position near or in a direction toward the clinician. The terms "distal" and "proximal" are used in the following description in reference to a device to be implanted in a blood vessel, such as a heart valve prosthesis, are used with reference to the direction of blood flow. Thus, "distal" and "distally" refer to a position in a downstream direction with respect to the direction of blood flow, and the terms "proximal" and "proximally" refer to a position in an upstream direction with respect to the direction of blood flow.

[0044] The following detailed description is merely exemplary in nature and is not intended to limit the application or the application and uses of the application. Although the description of the application is in the context of an elliptical heart valve prosthesis and a system and method for deploying an elliptical heart valve prosthesis at the site of a native heart valve, the application can be used in other body passageways where it is deemed useful. Furthermore, the application is not intended to be bound by any expressed or implied theory presented in preceding background, brief summary or detailed description of the application.

[0045] The application, in various embodiments, is directed to an elliptical heart valve prosthesis for replacing a native heart valve. Figures 1 to 7 An elliptical heart valve prosthesis 100 according to an embodiment of the application is shown. As described in more detail below, the heart valve prosthesis is substantially elliptical when viewed in cross-section. The heart valve prosthesis 100 includes a frame 102 that supports a prosthetic valve 104. The heart valve prosthesis 100 has a radially collapsed configuration for delivery and a radially expanded configuration when deployed.

[0046] As Figure 1 and 2As shown, the frame 102, also referred to as a stent or support structure, is a structure that includes a lumen 106 extending from an inflow end 108 to an outflow end 110 of the frame 102. The frame 102 includes a radially collapsed state for delivery corresponding to a radially collapsed configuration of the heart valve prosthesis 100, and a radially expanded state when deployed corresponding to a radially expanded configuration of the heart valve prosthesis 100. The frame 102 is configured to engage tissue at the annulus of a native heart valve when the frame 102 is in the radially expanded state. The frame 102 is also configured to provide a secure mounting surface for the valve component 104. The frame 102 includes a plurality of struts 114 connected by bend segments or crowns 116 to form a plurality of bands 112. Each band 112 is coupled with an adjacent band 112 at adjacent crowns 116 to form the frame 102. Although described as separate bands 112 connected together, this is not meant to be limiting and the frame 102 can be formed as one piece, such as by laser cutting a tube into the desired pattern.

[0047] Each strut 114 of the plurality of struts 114 includes a segment stiffness coefficient k, hereinafter referred to as "stiffness," as described below. The stiffness of each strut 114 of the plurality of struts 114 is varied such that, when the frame 102 is in the radially expanded state, the frame 102 is substantially elliptical when viewed in a cross-section perpendicular to a central longitudinal axis LA of the frame 102. As used herein, the term "substantially elliptical" or "substantially elliptical shape" means that the structure has an approximate elliptical shape having a major axis and a minor axis substantially perpendicular to the major axis, and the length of the major axis is greater than the length of the minor axis. However, the shape need not be a mathematical ellipse such that an oval shape falls within the scope of "substantially elliptical" or "substantially elliptical shape." As used herein, the term "substantially perpendicular" with respect to the major axis and the minor axis of an ellipse or elliptical shape means that the major axis and the minor axis intersect at an angle of about 90° plus or minus 10°. Figure 3 As shown, the substantially elliptical frame 102 includes a major axis 118 and a minor axis 120, where the major axis 118 is longer than the minor axis 120. As used herein, the term "substantially elliptical" or "substantially elliptical shape" means that the structure has an approximate elliptical shape having a major axis and a minor axis substantially perpendicular to the major axis, and the length of the major axis is greater than the length of the minor axis. However, the shape need not be a mathematical ellipse such that an oval shape falls within the scope of "substantially elliptical" or "substantially elliptical shape." As used herein, the term "substantially perpendicular" with respect to the major axis and the minor axis of an ellipse or elliptical shape means that the major axis and the minor axis intersect at an angle of about 90° plus or minus 10°.

[0048] Each crown 116 is formed by a pair of struts 114, as shown. Figure 4 As shown, each strut 114 includes a stiffness k, which is a measure of the stiffness of the strut 114, or in other words, a measure of the ability of the strut 114 to flex or not flex. The stiffness of each strut 114 can be represented by the following equation:

[0049] k = EtW 3 / 2L 3 cos 2 θ

[0050] In this equation, E is the modulus of elasticity of the material, t is the thickness of the wall of the segment or strut 114, W is the width of the segment or strut 114, L is the length of the segment or strut 114, and Θ is the deployment angle. As shown, Figure 4 the width W is measured from an outer surface of the strut 114 to an opposite outer surface of the strut 114. With the modulus of elasticity E, the wall thickness t, the length L, and the deployment angle Θ of each strut 114 remaining constant, the stiffness k of each strut 114 can be varied by varying the width W of each strut 114. In embodiments of the present application, the stiffness of the plurality of struts 114 is varied by varying the width W of at least one of the plurality of struts 114. The greater the width W of a strut 114, the greater the stiffness k and the less flexible the strut 114. Thus, a strut 114 having a greater width W is less flexible than a strut 114 having a smaller width W, all other factors being equal. As shown, Figures 3 to 4 varying the width W of the plurality of struts 114 at the inflow end 108 varies the stiffness k of the plurality of struts 114. A strut 114 having a greater width W and corresponding greater stiffness k is less flexible and expands less radially than a strut 114 having a smaller width W and corresponding smaller stiffness k. Varying the width W of the plurality of struts 114 of the frame 102 allows the frame 102 to expand into an oval shape when expanded to the radially expanded state.

[0051] In the embodiment shown in Figures 1 to 7 the frame 102 includes eighteen (18) crowns 116 at the inflow end 108 and eighteen (18) crowns 116 at the outflow end 110. Further, as best shown in Figures 3 to 4 each strut 114 of the plurality of struts 114 is formed to have one (1) of five (5) possible widths, a first width W1, a second width W2, a third width W3, a fourth width W4, or a fifth width W5. In particular, Figure 3 one embodiment is shown in which each crown 116 is a first crown 116a, a second crown 116b, a third crown 166c, a fourth crown 116, or a fifth crown 116e. Figure 4It is shown that each first crown 116a is formed between two first struts 114a, each first strut 114a having a first width W1. Similarly, each second crown 116b is formed between two second struts 114b, each second strut 114b having a second width W2; each third crown 116c is formed between two third struts 114c, each third strut having a third width W3; each fourth crown 116d is formed between two fourth struts 114d, each fourth strut having a fourth width W4; and each fifth crown 116e is bounded by two fifth struts 114e, each fifth strut 114e having a fifth width W5. The first width W1 is less than the second width W2, the second width W2 is less than the third width W3, the third width W3 is less than the fourth width W4, and the fourth width W4 is less than the fifth width W5. In Figures 3 to 4 In embodiments, the inflow end 108 of the frame 102 includes two (2) first crowns 116a, four (4) second crowns 116b, four (4) third crowns 116c, four (4) fourth crowns 116d, and four (4) fifth crowns 116e.

[0052] The particular pattern or arrangement of pairs of struts 114a-e and corresponding crowns 116a-e allows the frame 102 to expand into a predictably designed elliptical shape. When in the radially expanded state, the frame 102 includes a major axis 118 and a minor axis 120. As shown, the first struts 114a, having the first width W1 (the smallest), are disposed proximate the ends of the major axis 118, and the fifth struts 114e, having the fifth width W5 (the largest), are disposed proximate the ends of the minor axis 120. The difference in width W of each strut 114, as well as the arrangement of the struts 114, can be selected to provide a particular ellipticity when the frame 102 is in the radially expanded state. Figure 3

[0053] Referring next to Figure 5 , Figure 5 It is shown that the inflow end 108 of the frame 102 is shown in partial side view, each crown 116 includes an inner arc 140. Each inner arc 140 is an inner curve facing an acute angle I° of each crown 116. When the frame 102 is in the radially contracted state, the inner arc 140 of each crown 116 is substantially the same. As used herein, the term "substantially" or "generally" means approximately, the inner arc 140 of each crown 116 is equal within nominal manufacturing tolerances. However, as the frame 102 expands, the struts 114 proximate each crown 116 move in opposite directions (i.e., away from each other), as shown by arrows 130, 132. Thus, as the frame 102 expands, the inner arc 140 of each crown 116 is no longer substantially the same, as shown by arrows 134, 136. Figure 5 ​As indicated by the middle arrow 134, the crowns 116 are axially drawn toward the longitudinal middle portion of the frame, thereby increasing the angle I°. The width W of each strut 114 adjacent the corresponding crown 116 determines the amount of increase of the angle I° of the inner camber 140 and the axial distance that the crowns 116 move in the direction of the arrow 134 during radial expansion of the frame 102.

[0054] When the frame 102 is in the radially contracted state, the plurality of crowns 116 at the inflow end 108 are non-planar, or not aligned in the first plane PL1, as shown. Figure 6 In other words, the plurality of crowns 116 at the inflow end 108 are not aligned in the first plane PL1 that is perpendicular to the central longitudinal axis LA of the frame 102. Furthermore, as best shown in Figure 7 the plurality of struts 114 at the inflow end 108 of the frame 102 have non-uniform lengths. More specifically, the crown 116a formed by the struts 114a having the first width W1 has the greatest length L and extends axially the greatest distance from the inflow end 108 in the radially contracted state. The greater the width W of each strut 114 of the corresponding crown 116, the shorter the length L of the strut 114, and the less the corresponding crown 116 extends from the end 108 when the frame 102 is in the radially contracted state. During radial expansion of the frame 102, the first crown 116a formed between the first struts 114a having the first width W1 (smallest) moves axially the greatest distance in the direction of the arrow 134 compared to the other crowns 116. Furthermore, the greater the width W of each strut 114 adjacent the corresponding crown 116, the less the distance that the corresponding crown 116 moves axially upon expansion. Thus, the crowns 116 at the inflow end 108 of the frame 102 move axially during radial expansion such that when the frame 102 is in the radially expanded state, the plurality of crowns 116 at the inflow end 108 are substantially planar, or aligned in the second plane PL2, as shown. Figure 1 Although Figures 1 to 7 radial expansion at the inflow end 108 of the frame 102 is shown and described, this is by way of example only and not limitation. It should be understood that the outflow end 110 of the frame 102 is similarly configured and that the description of the movement of the crowns 116 and the corresponding inner camber 140 applies equally to the crowns 116 and the corresponding inner camber 140 at the outflow end 110.

[0055] While each strut 114 is described herein as having one (1) of five (5) different strut widths W1 through W5, this is by way of example and not limitation, and in other embodiments, the frame 102 may include a plurality of struts 114, wherein each strut 114 includes a width W from a greater or lesser set of possible widths. Additionally, while the frame 102 has been described as having eighteen (18) crowns 116 at each of the inflow end 108 and the outflow end 110, this is also by way of example and not limitation. In other embodiments, the frame 102 may include more or fewer crowns 116 at the inflow end 108 and the outflow end 110. Additionally, while Figures 1 to 7 Frame 102 is shown in FIG. 1 having a particular pattern of strut widths W around frame 102 to achieve a particular ellipticity, but the present invention is not limited to the pattern shown. The width of each strut 114, as well as the distribution pattern of struts 114 having varying widths W around frame 102, can be varied to provide a desired ellipticity. For example, the ellipticity of frame 102 of heart valve prosthesis 100 can be in the range of 1.0 to 1.8.

[0056] exist Figures 1 to 7 In an embodiment of the present invention, the heart valve prosthesis 100 is configured as a replacement for a native aortic valve. When configured as a replacement for a native aortic valve, the inflow end 108 of the frame 102 extends into and is anchored within the aortic valve annulus of the patient's left ventricle, and the outflow end 110 of the frame 102 is positioned in the patient's ascending aorta.

[0057] As described herein, the heart valve prosthesis 100 can be expanded from a radially contracted configuration to a radially expanded configuration. More specifically, the frame 102 is balloon expandable or mechanically expandable from a radially contracted state to a radially expanded state. As used herein, "balloon expandable" or "mechanically expandable" refers to plastic deformation of a structure so that the structure remains in a radially expanded state after being radially expanded by a suitable balloon or other mechanical expansion device. The frame 102 can be made of materials such as cobalt-chromium alloys (e.g., MPN35, L605), platinum-iridium, platinum-chromium, or stainless steel alloys (e.g., 316L), as well as other suitable materials known to those skilled in the art.

[0058] Alternatively, in another embodiment, the heart valve prosthesis can be self-expanding. As used herein, “self-expanding” refers to a structure having shape memory to return to a radially expanded configuration. Shape memory can be imparted on the structure forming the frame using techniques understood in the art. In embodiments where the frame is self-expanding, the frame can be held in a radially collapsed state for delivery by methods and devices understood by those skilled in the art. For example, but not by way of limitation, a self-expanding elliptical heart valve prosthesis can be held in a radially collapsed configuration by a suitable sheath or capsule or tie-down mechanism. Suitable tie-down mechanisms and assemblies for holding a self-expanding heart valve prosthesis are described in U.S. Patent No. 9,629,718 to Gloss, which is incorporated by reference herein in its entirety. Suitable sheaths or capsules for a delivery catheter are described, for example, in U.S. Patent No. 8,926,692 to Dwork, which is incorporated by reference herein in its entirety.

[0059] As previously described, the valve prosthesis 100 includes a prosthetic valve 104 disposed within the lumen 106 of the frame 102. The prosthetic valve 104 can also include a skirt secured to the frame 102. The prosthetic valve 104 is configured as a one-way valve to allow blood to flow in one direction and prevent blood from flowing in the opposite direction. The prosthetic valve 104 blocks flow in one direction to regulate flow via the valve leaflets. More particularly, and with reference back to Figure 3 In embodiments, the prosthetic valve 104 includes four (4) valve leaflets 122, 124, 126, 128. The valve leaflets 122, 124, 126, 128 form a replacement valve that opens due to a pressure differential such that the pressure on the inflow side of the valve leaflets 122, 124, 126, 128 is greater than the pressure on the outflow side of the valve leaflets 122, 124, 126, 128. The prosthetic valve 104 closes when the pressure on the outflow side of the valve leaflets 122, 124, 126, 128 is greater than the pressure on the inflow side. The valve leaflets 122, 124, 126, 128 can be sewn or otherwise securely and sealingly attached to the inner circumference of the frame 102 as understood by those skilled in the relevant art.

[0060] The valve leaflets 122, 124, 126, 128 of the prosthetic valve 104 can be made from natural pericardial material obtained from, for example, heart valves, aortic roots, aortic walls, aortic leaflets, pericardial tissue, bypass grafts, blood vessels, intestinal submucosal tissue, umbilical tissue, and the like from humans or animals, such as tissue from a cow, horse, or pig. Alternatively, the valve leaflets of the prosthetic valve 104 can be made from synthetic materials suitable for use as heart valve prosthesis leaflets in embodiments herein including, but not limited to, polyester, polyurethane, cloth materials, nylon blends, and polymeric materials.

[0061] While the prosthetic valve 104 is shown as having a particular pattern of leaflets 122, 124, 126, 128, the present invention is not limited to Figure 3 the pattern shown. For example, but not by way of limitation, in alternative embodiments, the prosthetic valve 104' can include leaflets 122', 124', 126', 128' as shown in the pattern shown. Figure 8

[0062] Reference is made to Figures 1 to 7 The oval-shaped valve prosthesis 100 shown and described is shown as a monolithic valve prosthesis, where the frame 102 and the prosthetic valve 102 are connected together as a single piece, and are delivered to the treatment site, and then deployed, as described in more detail below. However, the present invention is not limited to such embodiments. In other embodiments, the oval-shaped frame as described above can not include a prosthetic valve, such that the oval-shaped frame is deployed for use as an anchoring stent. Then, a valve prosthesis as described above can be delivered and deployed within the already-deployed anchoring stent. As described above, the valve prosthesis in such embodiments can or can not be oval-shaped. Since the anchoring stent has already been deployed within the annulus of the native heart valve, the frame of the valve prosthesis can have a smaller outward radial force to hold its position, since the frame is coupled with the anchoring stent. Since the frame of the valve prosthesis does not need to have as large of a radial force, such embodiments enable a smaller overall delivery profile, and thus can be thinner, such that it can be crimped to a smaller diameter for delivery.

[0063] Figures 9 to 1 2An embodiment of a system 301 for percutaneously delivering and deploying a heart valve prosthesis, such as the heart valve prosthesis 100 previously described herein, to a site of a native heart valve is shown. The system 301 includes a delivery catheter 303 and the heart valve prosthesis 100. The delivery catheter 303 includes a handle 305, an outer shaft 307, an inner shaft 309, a distal tip 311, and a balloon 313.

[0064] The balloon 313 is coupled with a distal portion of the outer shaft 307 and a distal portion of the inner shaft 309, as described in more detail below. As previously described, the heart valve prosthesis 100 can be crimped onto the balloon 313 in a radially-contracted configuration for delivery to the native heart valve, and can then be deployed by inflating the balloon 313 to radially expand the heart valve prosthesis 100 into a radially-expanded configuration. The cross-section of the balloon 313 can also be oval-shaped to enable smooth expansion of the oval-shaped valve prosthesis 100. Thus, the major axis 118 of the heart valve prosthesis 100 is circumferentially or rotationally aligned with a major axis 339 of the balloon 313, as shown in FIG. 12 and described below.

[0065] The handle 305 provides a surface that facilitates user manipulation and gripping. While Figure 9 ​The handle 305 is shown as having a generally cylindrical shape, but this is by way of example and not limitation, and other shapes and sizes may be used.

[0066] Likewise Figures 9 to 11 As shown, the inner shaft 309 includes a lumen 317 disposed therethrough. The lumen 317 is commonly referred to as a guidewire lumen, so that a guidewire can be inserted into a distal port 329 of the lumen 317 so that the delivery catheter 303 can be tracked over the guidewire to the treatment site, as is known to those skilled in the art. The inner shaft 309 includes a proximal end 332 that is coupled to the handle 305 and includes a proximal port 331 for extending a guidewire through and into the lumen 317. The inner shaft also includes a distal end 325 coupled to the distal tip 311 and to the balloon 313, as described in more detail below.

[0067] The outer shaft 307 of the delivery catheter 303 also includes a lumen 315 extending therethrough. The lumen 315 forms an annular inflation lumen between the outer surface of the inner shaft 309 and the inner surface of the outer shaft 307. At least a portion of the outer shaft 307 is configured for fixed connection to the handle 305. In one embodiment, a proximal end 319 of the outer shaft 307 can extend through the handle 305 and be coupled to the handle 305. The distal end 321 of the outer shaft is connected to a balloon, as explained in more detail below.

[0068] Although the outer shaft 307 and the inner shaft 309 are described herein as each being a single component, this is by way of example and not limitation, and the shafts 307, 309 may each comprise multiple components, such as, but not limited to, a proximal shaft and a distal shaft, or other components suitable for the purposes described herein. The outer shaft 307 and the inner shaft 309 may be formed from materials such as, but not limited to, polyurethane (e.g., Elasthane TlVl 、 ), polyamide polyether block copolymers (e.g., Nylon 12), polyethylene, or other suitable materials.

[0069] Furthermore, although the outer shaft 307 and the inner shaft 309 are described herein as two shafts arranged coaxially, as shown in FIG. Figure 12A For example, but not by way of limitation, there may be a single shaft 307' comprising both an inflation lumen 315' and a guidewire lumen 317', as is known to those skilled in the art, and as Figure 12B shown.

[0070] like Figures 9 to 11As shown, a proximal neck 323 of the balloon 313 is attached to a distal end 321 of the outer shaft 307. The outer shaft 307 terminates at an interior of the balloon 313 such that inflation fluid injected through the inflation lumen 315 exits the inflation lumen 315 at the interior of the balloon 313 to inflate the balloon 313. A distal neck 327 of the balloon 313 is attached to a distal end 325 of the inner shaft 309. The balloon 313 can be attached proximally and distally to the outer shaft 307 and the inner shaft 309, respectively, by adhesive, fusion, mechanical connection, or other methods known to those of skill in the art. Alternatively, in Figure 12B the illustrated embodiment, both the proximal neck 323 and the distal neck 327 of the balloon 313 are attached to a single shaft 307', and the inflation lumen 315' includes a port 351' exiting the shaft 307' between the proximal neck 323 and the distal neck 327 to inflate the balloon 313, as known to those of skill in the art and illustrated in Figure 12C .

[0071] As shown, the distal tip 311 includes an inner lumen 335 extending therethrough. The inner lumen 335 is sized to accommodate the distal end of the inner shaft 309 and provide a continuous inner lumen in communication with the inner lumen 317 of the inner shaft 309. The distal tip 311 can be coupled to the inner shaft 309 by methods such as, but not limited to, adhesive, bonding, welding, fusion, mechanical connection, or other suitable coupling methods. Figures 9 to 11

[0072] When the interior of the balloon 313 is filled with inflation fluid, the balloon 313 inflates into an inflated or radially expanded state. As shown, Figure 13 the inflated balloon 313 is substantially elliptical in cross-section transverse to a central longitudinal axis of the balloon 313. Accordingly, the inflated balloon 313 includes a major axis 339 and a minor axis 341 in cross-section, as shown. Figure 13 The major axis 339 is longer than the minor axis 341. In Figure 13 embodiments, the heart valve prosthesis 100 is omitted for clarity. The balloon 313 is configured to transition from an uninflated state to an inflated state to cause the heart valve prosthesis 100 to radially expand from a radially compressed configuration to an elliptical radially expanded configuration at a site of a native heart valve. Accordingly, the elliptical shape of the balloon 313 in the inflated state corresponds to the elliptical shape of the heart valve prosthesis 100 in the radially expanded configuration. Although the illustrated balloon 313 has a particular ellipticity, it is understood that this is by way of example and not limitation, and alternative ellipticities can be utilized. For example, the ellipticity of the balloon 313 can be in the range of 1.0 to 1.8. The balloon 313 can be a standard non-compliant or semi-compliant balloon constructed of materials such as, but not limited to, polyethylene terephthalate (PET), nylon, or polyurethane, among others.

[0073] ​In one embodiment, the delivery catheter 303 includes a radiopaque marker 343, such as Figures 9 to 11 As shown. Figures 9 to 11 In the illustrated embodiment, the marker 343 is attached to the inner shaft 309 or to a portion of the inner shaft 309 adjacent the distal end 325 of the inner shaft 309. However, this is not meant to be limiting and may be used in conjunction with other embodiments of the present invention. Figures 12B to 12C In one embodiment, marker 343 can be attached to outer shaft 307 or a portion of outer shaft 307 proximate the distal end of outer shaft 307 or proximate the distal end of shaft 307'. In one embodiment, marker 343 includes a head 345 and a tail 347 extending substantially perpendicular to head 345. Tail 347 of marker 343 is circumferentially aligned with one of axes 339, 341 of balloon 313. For example, tail 347 can be circumferentially aligned with major axis 339 of balloon 313. Furthermore, heart valve prosthesis 100 is crimped onto balloon 313 such that major axis 118 of frame 102 is aligned with major axis 339 of balloon 313 and, therefore, with tail 347 of marker 343. Thus, when delivered to the treatment site, the treating clinician can align the tail 347 of the marker 343 with the greater axis of the annulus of the native heart valve so that the major axes 118, 339 of the heart valve prosthesis 100 and balloon 313, respectively, are aligned with the greater axis of the annulus. Figure 10 and 11 It can be seen that when viewing the delivery catheter 303, the treating clinician can determine whether the major axis 118, 339 is aligned with the visual field provided. Figure 1 To, such as Figure 10 , or if it is not aligned with the view, as shown Figure 11 As shown, Figure 11 The major axis 118, 229 is shown rotated approximately 90 degrees.

[0074] The marker 343 may be formed of a material such as, but not limited to, platinum, gold, platinum-iridium, or any other suitable material. The marker 343 may be coupled to the inner shaft 309, outer shaft 307, or shaft 307' by, for example, but not limited to, an adhesive, bonding, welding, fusing, mechanical connection, or other suitable coupling method, or may be formed as part of the shaft. The term "radio-opaque" refers to the ability of a substance to absorb X-rays. Few substances transmit 100% of X-rays, and few substances absorb 100% of X-rays. For the purposes of this disclosure, "radio-opaque" will refer to those substances or materials that have suitable visibility for heart valve surgery when imaged by an X-ray imaging device, such as, but not limited to, a fluoroscope.

[0075] Although marker 343 is shown as having a head 345 and a tail 347, this is not meant to be limiting and other designs may be used to enable the treating clinician to align the marker with the greater or lesser axis of the annulus AN of the native heart valve AV, as explained in more detail below.

[0076] Figures 14 to 17 is a cross-sectional view of a heart HE, showing a method for using a heart HE according to an embodiment of the present invention. Figure 9 The system 301 provides a method for delivering, positioning, and deploying a heart valve prosthesis 100. Figure 14 , the system 301 is shown as having been introduced into the vasculature via a percutaneous access point (e.g., via the Seldinger technique) and tracked through the vasculature and into the aorta AO until the heart valve prosthesis 100 is proximal to and / or juxtaposed with the annulus AN of the native aortic valve AV. Intravascular access to the aorta AO can be achieved by accessing the aorta AO via a percutaneous access site through the femoral artery or other known access routes. Thereafter, a guidewire GW is advanced through the circulatory system and ultimately reaches the heart HE. Once the guidewire GW is positioned, the guide catheter GC is advanced through the vasculature and positioned near or downstream of the native aortic valve AV. The proximal end of the guidewire can then be loaded into the port 329 at the distal end of the delivery catheter 303, and the delivery catheter can be advanced over the guidewire to the treatment site. Although described herein as a transfemoral approach for percutaneous access to the native aortic valve AV, the heart valve prosthesis 100 can be positioned in the desired area of ​​the heart HE by other methods. Furthermore, although the use of a guide catheter GC and a guidewire GW is described, in another embodiment herein, the delivery catheter 303 may enter the aorta AO without the use of a guidewire GW and / or a guide catheter GC.

[0077] Refer again Figure 14 As will be appreciated, system 301 is assembled with heart valve prosthesis 100 loaded onto delivery catheter 303, wherein heart valve prosthesis 100 is in a radially collapsed configuration and positioned around the outer surface of balloon 313 in an uninflated state, with the major axis 118 of frame 102 of heart valve prosthesis 100 circumferentially aligned with the tail 347 of marker 343. With system 301 thus assembled, system 301 is advanced to the site of the native aortic valve AV until heart valve prosthesis 100 is positioned within the annulus AN of the native aortic valve AV.

[0078] like Figure 14 As shown, the marker 343 on the delivery catheter 303 is seen on the left side of the inner shaft 309. Thus, the major axes 118, 339 of the frame 102 and balloon 313 are respectively relative to Figure 14 The view is rotated 90 degrees. In other words, the major axis 118, 330 is inFigure 14 If Figure 14 If the view is such that the long axis of the annulus AN of the native aortic valve is lateral, no further action is required. However, if the greater axis of the annulus AN is lateral, Figure 14 If the view is anteroposterior, the long axes 118, 339 of the frame 102 and balloon 303 are not aligned with the long axis of the annulus AN. Figure 15 As shown, the handle 305 can be rotated (in Figures 14 to 17 The marker 343 is rotated counterclockwise (not visible in the figure) (in this example, counterclockwise in the direction of arrow 358) to align the tail 347 of the marker 343 with the long axis of the annulus AN of the native aortic valve AV. The radial alignment of the long axis 118 of the frame 102 of the heart valve prosthesis 100 and the long axis of the annulus AN of the heart HE ensures optimal sealing of the elliptical-shaped heart valve prosthesis 100 with the elliptical-shaped annulus AN to prevent paravalvular leakage (PVL) when the heart valve prosthesis 100 is deployed therein. Those skilled in the art will understand that in other embodiments, instead of aligning the tail 347 of the marker 343 with the long axes 118, 339 of the frame 102 and balloon 339, the tail 347 of the marker 343 can be aligned with the short axes 120, 341 of the frame 102 and balloon 339 so that the treating clinician can align the tail 347 with the short axis of the annulus AN. Depending on the fluoroscopic view used, it may be desirable that the tail 347 be visible "in front" of the delivery catheter 303 when the delivery catheter 303 is properly aligned, as shown. Figure 15 shown.

[0079] When the heart valve prosthesis 100 is properly aligned with and positioned within the annulus AN of the native aortic valve AV, and the clinician is ready to deploy the heart valve prosthesis 100, inflation fluid under pressure is introduced through the inflation port 353 ( Figure 9 ) is pumped into the inflation lumen 315 so that the inflation fluid exits the outer shaft 307 and the distal opening of the balloon 313 to inflate the balloon 313, as shown in FIG. Figure 16 As shown, when balloon 313 transitions from an uninflated state to an inflated state, balloon 313 radially expands the heart valve prosthesis 100 positioned thereon from a radially contracted configuration to an elliptically radially expanded configuration. Heart valve prosthesis 100 plastically deforms to the radially expanded configuration and engages tissue at the annulus AN of the native aortic valve AV. In the preceding step, the co-aligned long axis 339 of balloon 313 and the co-aligned long axis 118 of frame 102 of heart valve prosthesis 100 are aligned with the long axis of the annulus AN of the native aortic valve AV, ensuring that heart valve prosthesis 100 fully expands and sealingly conforms to the substantially ellipsoidal shape of the annulus AN of the native aortic valve AV.

[0080] With successful positioning and deployment of the heart valve prosthesis 100 within the annulus AN of the native aortic valve AV, the pressure on the inflation fluid is released and the inflation fluid flows out of the balloon 313 and through the inflation lumen 315, causing the balloon 313 to transition from the inflated state to the uninflated state. Once the balloon 313 is in the uninflated state, the delivery catheter 303, the guide catheter GC, and the guidewire GW can be removed using established procedures. With the removal of the delivery catheter 303, the heart valve prosthesis 100 is held in place at the annulus AN of the native aortic valve AV, as shown in Figure 17 .

[0081] Imaging guidance, e.g., intracardiac echocardiography (ICE), fluoroscopy, computed tomography (CT), intravascular ultrasound (IVUS), optical coherence tomography (OCT), or other suitable guidance modalities, or combinations thereof, can be used to assist the clinician in the delivery positioning and radial alignment of the heart valve prosthesis 100.

[0082] While the method is described with the heart valve prosthesis 100 of Figures 1 to 7 and the system 301 of Figures 9 to 13 , this is not meant to be limiting. It is understood that other embodiments of substantially elliptical heart valve prostheses can be used in a similar manner. Figures 14 to 17

[0083] While the method has been described with respect to the delivery, positioning, radial alignment, and deployment of the heart valve prosthesis at the site of the native aortic valve, the method can be used at other locations.

[0084] While only some embodiments according to the present application have been described herein, it is understood that the described embodiments are presented by way of example only, and are not limiting as to the scope of the application. Various changes and modifications can be made to form various embodiments within the spirit and scope of the application. Further, each of the embodiments discussed herein, as well as each of the features of each of the references cited herein, can be used in combination with the features of any other embodiment. All patents and publications discussed herein are hereby incorporated by reference in their entirety.​

Claims

1. A heart valve prosthesis comprising: a frame comprising an inner lumen, the frame comprising a plurality of bands, an inflow end, and an outflow end opposite the inflow end, the plurality of bands extending circumferentially about a central longitudinal axis of the frame and comprising a plurality of struts and a plurality of crowns, wherein the frame comprises a radially contracted state and a radially expanded state; and a prosthetic valve disposed within the lumen of the frame, wherein the stiffness of the plurality of struts in one of the plurality of bands varies around the circumference of the frame such that a cross-section of the frame transverse to the central longitudinal axis is substantially elliptical when the frame is in the radially expanded state; wherein the stiffness of the plurality of struts is varied by varying the corresponding widths of the plurality of struts, wherein in the band of varying stiffness of the frame, the width of each of the plurality of struts is selected from the group consisting of a first strut width, a second strut width, a third strut width, a fourth strut width, and a fifth strut width, wherein the band of varying stiffness includes at least one strut of each of the first strut width, the second strut width, the third strut width, the fourth strut width, and the fifth strut width.

2. A heart valve prosthesis according to claim 1, wherein the stiffness of the multiple struts is varied by varying the width of at least one of the multiple struts, and wherein when the frame is in the radially expanded state, at least one of the multiple struts having the largest width is positioned adjacent to the long axis of the frame, and at least one of the multiple struts having the smallest width is positioned adjacent to the short axis of the frame.

3. The heart valve prosthesis of claim 1, wherein at least one of the inflow end or the outflow end of the frame comprises eighteen crowns formed by struts of the plurality of struts.

4. A heart valve prosthesis according to claim 3, wherein each of the eighteen crowns is formed by two struts, so that the plurality of struts consists of thirty-six struts, the thirty-six struts including four struts having the first strut width, eight struts having the second strut width, eight struts having the third strut width, eight struts having the fourth strut width and eight struts having the fifth strut width, wherein the second strut width is greater than the first strut width, the third strut width is greater than the second strut width, the fourth strut width is greater than the third strut width, and the fifth strut width is greater than the fourth strut width.

5. A heart valve prosthesis according to claim 4, wherein the crown formed by the struts having the fifth strut width is positioned adjacent to the short axis of the frame, and the crown formed by the struts having the first strut width is positioned adjacent to the long axis of the frame.

6. A heart valve prosthesis according to claim 1, wherein when the frame is in the radially contracted state, the multiple crowns at at least one of the inflow end or the outflow end are non-planar, and when the frame is in the radially expanded state, the multiple crowns at at least one of the inflow end or the outflow end are substantially planar. 7 . The heart valve prosthesis of claim 1 , wherein the plurality of struts at the inflow end have non-uniform lengths, and the plurality of struts at the outflow end have non-uniform lengths.

8. A heart valve prosthesis according to claim 1, wherein at least one of the inflow end or the outflow end includes a crown among the multiple crowns, and wherein the width of each of the multiple struts forming the crown at the outflow end or the inflow end is selected from the group consisting of a first strut width, a second strut width, a third strut width, a fourth strut width and a fifth strut width.

9. The heart valve prosthesis of claim 1, wherein the prosthetic valve comprises four leaflets.

10. The heart valve prosthesis of claim 1, wherein the frame is balloon expandable.

11. A system for percutaneously delivering a heart valve prosthesis to the site of a native heart valve, the system comprising: a delivery catheter; and A heart valve prosthesis comprising a radially collapsed configuration for delivery and a radially expanded configuration for deployment, the heart valve prosthesis comprising a frame and a prosthetic valve coupled to the frame, the frame having a plurality of circumferential bands, each of the circumferential bands comprising a plurality of struts and a plurality of crowns, wherein the heart valve prosthesis is positioned in the radially collapsed configuration at a distal portion of the delivery catheter for delivery to the site of a native heart valve, wherein when the heart valve prosthesis is in the radially expanded configuration, the heart valve prosthesis has a substantially elliptical shape in a cross-section transverse to a central longitudinal axis of the frame, the substantially elliptical shape being formed by varying the stiffness of at least one strut of a plurality of struts of a frame of the heart valve prosthesis; wherein the stiffness of the plurality of struts varies such that the stiffness varies from a first stiffness adjacent each end of the major axis in the cross-section of the frame to a second stiffness adjacent each end of the minor axis in the cross-section of the frame, with a third stiffness between each end of the major axis and each end of the minor axis, wherein the second stiffness is greater than the first stiffness and the third stiffness is between the first stiffness and the second stiffness.

12. The system of claim 11 , wherein the stiffness of the at least one strut is varied by changing a width of the at least one strut, and wherein when the heart valve prosthesis is in the radially expanded configuration, at least one of the plurality of struts having the largest width is positioned adjacent to a minor axis of the heart valve prosthesis, and at least one of the plurality of struts having the smallest width is positioned adjacent to a major axis of the heart valve prosthesis.

13. The system of claim 11, wherein The heart valve prosthesis is balloon expandable, The delivery catheter also includes a balloon located at a distal portion thereof, The balloon includes an inflated state in which the cross-section of the balloon is substantially elliptical, and The heart valve prosthesis in the radially collapsed configuration is positioned over the balloon in the uninflated state such that a major axis of the heart valve prosthesis is circumferentially aligned with a major axis of the balloon.

14. The system of claim 13, wherein the delivery catheter further comprises a radiopaque marker coupled thereto and aligned with the long axis of the balloon.

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